In his report, “Product Innovation Requires Laboratory Informatics Systems to Transcend Phases,”¹ Gartner analyst Michael Shanler recommends that manufacturers “prioritize end-to-end informatics investments and align metrics for innovation, domain expertise, operational efficiencies and quality.” His recommendation is based on an observation that today’s laboratories “are, for the most part, disconnected.”
The move to a more connected laboratory is driven by both the productivity drivers Gartner describes and significant technology improvements. The paperless lab has been discussed for the past 15–20 years, but it is finally happening and nowhere is this more evident than inside quality assurance/quality control (QA/QC) laboratories. Few QA/QC labs still cling to the paper-based notebook systems of the past and, while this is a critical step, it is only part of the story. There’s far more to becoming a paperless lab than simply eschewing paper. Labs must adopt a smart infrastructure that drives quality, not only in the lab, but throughout the organization. An integrated informatics solution is the engine that drives quality product release and a culture of continual process improvement.
QUALITY BY DESIGN
In 2004, the FDA introduced Quality by Design (QbD) in “Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach.”² While this concept is not new to many industries, it was the first attempt to apply these principles to the pharmaceutical industry. Quality by Design is built on the concept that well-understood products and processes are more efficient and produce higher-quality products resulting in less product nonconformance. The FDA’s goal was to improve pharmaceutical companies’ productivity, ensure patient safety, and prevent drug shortages in the marketplace. The quote below, from a 2012 FDA presentation on the pharmaceutical quality system, makes this point succinctly:
We rely upon the manufacturing controls and standards to ensure that time and time again, lot
after lot, year after year the same clinical profile will be delivered because the product will be
the same in its quality…. We have to think of the primary customers as people consuming that
medicine and we have to think of the statute and what we are guaranteeing in there, that the
drug will continue to be safe and effective and perform as described in the label.
(Janet Woodcock, M.D.)
Uncompromising quality is essential to any pharmaceutical company. Informatics plays a critical role in ensuring that organizations realize the improved product quality and operational efficiency provided by adherence to QbD principles.
TODAY'S INFORMATICS INFRASTRUCTURE
QA/QC laboratories need a tightly controlled process and a well-managed laboratory to drive predictive analytics and to prevent substandard products before they occur. An end-to-end informatics solution warns the organization before nonconformances occur by monitoring critical product attributes creating a proactive versus reactive environment. Laboratories address these needs through the use of several systems: Lab Execution Systems (LES), Scientific Data Management Systems (SDMS), and Laboratory Information Management Systems (LIMS).
LAB EXECUTiON SYSTEMS
LES has become a critical component of today’s paperless lab, ensuring that quality processes are followed in the laboratory and that the methods built on QbD principles are followed in day-to-day laboratory operations. LES drives users through any laboratory procedure in a stepwise fashion. This provides technicians with the direction they need to execute processes safely, and in a consistent manner. It also assures laboratory management that good laboratory practices (GLPs) are used and that standard operating procedures (SOPs) are being followed by experienced and newly trained laboratory personnel. Maintaining a consistent approach to activities like sample preparation, instrument calibration, maintenance, and analytical testing is critical to a good scientific process. Lab managers can then be certain that all of their results are a true assessment of final product quality.
SCIENTIFIC DATA MANAGEMENT SYSTEMS
An SDMS lets you integrate instruments across the lab and centralize data capture, allowing for long-term data archiving and, more importantly, data visualization from the archive—all accessed from the LIMS. An SDMS archives the original raw data files from the instrument along with a normalized representation in XML, without the need to restore the data to the original instrument workstation or install the instrument software on every computer.
The real scientific data and the results gleaned from them are a critical part of QbD. The final product specification is determined by comparing the analytical results to determine which formulation and process parameters yield the best product. As part of a paperless lab environment, an SDMS integrated with the LIMS reduces paperwork, manual review time, and data transcription, which improves efficiency, productivity, consistency, and quality while reducing costs dramatically. SDMS also provides secure access to archived files for as long as necessary, and enables more efficient and defensible reporting to regulatory authorities.
LABORATORY INFORMATION MANAGEMENT SYSTEMS
LIMS remains a critical part of the infrastructure of any pharmaceutical manufacturing organization. Today’s LIMS goes far beyond just the management of samples, tests, and results. It also provides resource management, allowing organizations to forecast fewer sample volume and resource needs. It provides dashboard views that allow organizations to see how their lab is operating and identify any data that are trending toward warning or failure limits. These lab management activities are essential, but organizations need to be able to drive the day-to-day operations of the laboratory as well.